CBM, Core Build-Up Material
FDA 510(k) K823732 · Scientific Pharmaceuticals, Inc.
510(k) numberK823732
Submission
- Device name
- CBM, Core Build-Up Material
- Applicant
- Scientific Pharmaceuticals, Inc.
Mchenry, IL, US - Received
- December 10, 1982
- Decision date
- December 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was CBM, Core Build-Up Material cleared by the FDA?
CBM, Core Build-Up Material (K823732) received a 510(k) decision of Substantially Equivalent on December 28, 1982, 18 days after the submission was received.
What is the product code of K823732?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.